Acute Back Pain
Conditions
Keywords
Acute Back Pain, Battlefield Acupressure, Auricular Acupressure
Brief summary
Patients frequently present to the emergency department for treatment of acute pain. In the emergency department, analgesic medications, particularly opiates, are most often the primary and only means of treatment. Alternative therapies such as traditional acupuncture have been studied and utilized in acute care settings; however, the need for extensive training, the use of needles, and state-specific acupuncture licensing requirements have been barriers to widespread use. Battlefield Auricular Acupressure (BAA) is a needle-free five-point technique on the outer ear that has been developed and employed by the military for a variety of painful conditions. The primary objective of this study is to determine if battlefield auricular acupressure (BAA), compared to a sham procedure, results in a reduction in pain score at 30 minutes and 60 minutes post-intervention, by at least 2 Numerical Rating Scale (NRS) points below their baseline pain score, compared to participants receiving a sham procedure, for adults who present to the emergency department with a chief complaint of back pain and/or low back.
Interventions
PROCEDUREBattlefield auricular acupressure
Battlefield auricular acupressure: Ear seeds will be applied to the five established BAA points: Cingulate Gyrus, Thalamus, Omega 2, Point Zero, and Shen Men.
PROCEDURESham
Ear seeds will be applied to five pre-defined, non-therapeutic points on the ear helix and lobe, chosen for their lack of known effect on pain. The procedure will be identical in duration and interaction to the BAA group.
Sponsors
Hackensack Meridian Health
New Jersey Health Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient (Age ≥ 18) presenting to the ED * Chief complaint of back pain and/or low back pain * Pain score ≥ 4 on 0-10 NRS
Exclusion criteria
* Pregnancy * Known allergy to adhesive * Presence of cochlear implants * Piercings at one or more of the BAA or sham sites * Having received analgesic medications within 4 hours of arrival to the ED or prior to intervention * Preferred language other than Spanish or English * Presence of a wound, sore, or active infection on the surface of the ear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | Pain scores will be assessed at baseline (prior to intervention), 30 (± 5) minutes post-intervention and 60 (± 10) minutes post-intervention. | Pain scores will be measured using the Numeric Rating Scale (NRS) ranging from 0 ("no pain") to 10 ("worst pain imaginable")10. This study will compare the mean pain scores between the BAA group and the sham group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Non-Opioid Analgesic Medication Use | From intervention until ED disposition (on average 3.5 hours) | The proportion of patients in each group who require at least one dose of a non-opioid analgesic. |
| Total Opioid Consumption in Morphine Milligram Equivalents (MME) | From intervention until ED disposition (on average 3.5 hours) | A continuous variable representing the sum of all opioid doses received, converted to a standardized value. MME is a universal conversion system that turns all opioids into a single, standard unit using the formula: MME = (Dose of the Opioid in mg) x (Its Conversion Factor). |
| Incidence of Opioid Medication Use | From intervention until ED disposition (on average 3.5 hours) | The proportion of patients in each group (intervention vs. sham) who are administered an opioid analgesic following the intervention. This is a specific subset of analgesia and will be analyzed as a dichotomous (yes/no) outcome. |
| Change in Pain Score at 24 Hours | 24 hours post intervention | To assess the lasting effect of the intervention, a delayed follow-up 24-hour assessment will be conducted. Pain scores will be measured using the Numeric Rating Scale (NRS) ranging from 0 ("no pain") to 10 ("worst pain imaginable")10. Delayed follow-up pain score will be calculated as (NRS at 24 hours) - (NRS at baseline). |
| Incidence of Any Analgesic Medication Use | From intervention until ED disposition (on average 3.5 hours) | The proportion of patients in each group (intervention vs. sham) who require any analgesic medication following the intervention. This will be analyzed as a dichotomous (yes/no) outcome. |
| Frequency of Non-Opioid Analgesic Doses | From intervention until ED disposition (on average 3.5 hours) | A continuous variable representing the total number of doses of non-opioid analgesics administered stratified by drug class (NSAIDs vs acetaminophen). |
Countries
United States
Contacts
CONTACTDiana McCarthy, MSN, RN
PRINCIPAL_INVESTIGATORBiren Bhatt, MD
Hackensack Meridian Health
Outcome results
None listed